MAUDE Adverse Event Report: UNKNOWN 80 X 36 X 5.5 ECONOMY FOAM MATTRESS 1633 9153647264; CUSHION, FLOTATION

Model Number 5180

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer alleges that the mattress is bottomed out.

• Brand Name: 80 X 36 X 5.5 ECONOMY FOAM MATTRESS 1633 9153647264
• Type of Device: CUSHION, FLOTATION
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4431605
• MDR Text Key: 5384774
• Report Number: 1531186-2015-00403
• Device Sequence Number: 1
• Product Code: KIC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/19/2015,01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2015
• Distributor Facility Aware Date: 01/12/2015
• Date Report to Manufacturer: 01/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other